Emory University, Emory Clinic and its affiliated satellite Clinics, Grady Neighborhood Clinics, and the University affiliated hospital clinics (Wesley Woods and Grady Memorial Hospital) will collaborate to serve as a designated Clinical Center for the Full Scale Trial of Medical Therapy in Benign Prostatic Hyperplasia. The goals of this Center, which would be composed of an interdisciplinary team of clinical investigators and personnel (urology and primary care) who have experience in clinical trials involving medical management of BPH, would be (a) to enroll at least 200 men with BPH in the trial over a two year period, with at least half of these men belonging to an ethnic minority; (b) to ensure strict protocol compliance in terms of eligibility, treatment, follow-up, and data submission; (c) to provide data and monitoring procedures which are truly accurate and high quality; (d) to assist in further refinement of the study protocol prior to study enrollment and to attend all Steering Committee and other collaborative meetings; and (e) to foster study participant retention while maintaining good urological care for the study participants. Potential participants will be identified by team members from a variety of geographically dispersed and ethnically diverse primary care clinic sites, as well as from University and affiliated urological practices. Public information and the news media, including media targeted to the Atlanta African-American community, will further enhance recruitment efforts for the study. The combination of facilities, resources, personnel, and target population pools of the participating clinical sties, along with the documented leadership and experience in high-quality data management in clinical trials, will allow for the goals of this proposal to be met.
